Brazil strengthens its ban on ENDS, including e-cigarettes and heated tobacco products

On Friday, April 19, 2024, the board of ANVISA, the Brazilian Health Regulatory Agency strengthened its already-strong ban on electronic nicotine systems (ENDS), which includes e-cigarettes and heated tobacco products.

In stark contrast to the US Biden Administration, which just caved to industry pressure and blocked the FDA’s well-conceived ban on menthol cigarettes and flavored cigars, ANVISA resisted pressure from the multinational tobacco companies to water down its prohibition on the import and sale of ENDS. The industry mobilized all their usual arguments, that these products reduced harm, that legalization and regulation was a better policy than prohibition, and that they were already in Brazil (thanks to illicit trade, which the companies have a history of promoting).

While there is some use of these products, the reality is that Brazil (and other countries that prohibit ENDS imports is doing much better at preventing both youth and adult use than the United States which tries to regulate them.

	Youth	Adults
Brazil (2019)	2.8% (age 13-17)	0.6% (age 15+)
Turkey (2016)		1.1% (age 15+)
Thailand (2019)	3.7% (seventh grade)
US (2019)	27.5% (middle school) 10.5% (high school)	4.5% (age 18+)
Sources: Brazil 2019 National School Health Survey; Patanavich et al. Asian Pac J Cancer Prev. 2021;22(7):2199-2207; Cullen et al. JAMA. 2019;322(21):2095; Cornelius et al. MMWR 2020;69:1736; McCabe et al. J Adolesc Health. 2020;67:531; Obisesan et al. JAMA Intern Med. 2020;180:1394;

Instead of succumbing to industry arguments, the ANVISA Board adopted updated policies (summarized below) that maintained the ban, while improving the definition of covered products, prohibiting transportation of illegal products and clarifying that their use in public spaces is prohibited.

At the request of some colleagues from Brazil, I submitted a brief statement supporting the proposed ANVISA updated regulation.

Here is a summary of the newly updated regulation:

Art. 1 This Resolution order for the prohibition of the manufacture, import, commercialization, distribution, storage, transportation and advertising of electronic device to smoking (DEF).

Single paragraph. This resolution applies to all electronic device to smoking, as well as accessories, parts, parts and refills intended for use with/in electronic device to smoking.

Art. 2 For the purposes of this Resolution, the following definitions apply:

I – “smoking” product (actually a broader term, because in Portuguese it could go beyond just smoke): manufactured product, whether or not derived from tobacco, that contains leaves, leaf extracts, other plant components, synthetic or natural substances, or that mimic tobacco products;

II – electronic device to smoke: “smoking” product whose emissions are generated with the aid of a system powered by electricity, battery or other non-combustible source, which mimics the act of smoking, including:

a) disposable or reusable products;

b) products that use a solid and/or liquid matrix, or others, depending on their construction and design;

c) products composed of a unit that heats one or more matrices: liquid (with or without nicotine); solid (usually composed of tobacco extract or leaves – crushed, crumbled, ground, cut or whole, or other plants); composed of synthetic substances that reproduce tobacco components and extracts from other plants; by essential oils; by vitamin complexes, or other substances; It is

d) products known as electronic cigarettes, e-cigs, ENDS, ENNDS, e-pod, “pen-drive”, pod, vapes, heated tobacco product, heated tobacco product, heat not burn, vaporizers, among others.

III – other electronic device to smoking: these are electronic device to smoking with operation and/or matrices different from those provided for in section II of art. 2nd of this resolution;

…

Art. 3 The manufacture, import, commercialization, distribution, storage, transportation, advertising of all electronic device to smoking is prohibited.

§ 1 The following are included in the prohibitions referred to in the caput of this article:

I – any accessories, pieces, parts and refills intended for use with/in an electronic device to smoke;

II – other electronic devices to smoking with operation and/or matrices different from those defined in this resolution;

III – products and packaging, intended for children and young people, as well as food or food packaging, which simulate, imitate or reproduce the shape of electronic smoking devices, in accordance with Law No. 12,921, of December 26, 2013, and the Collegiate Board Resolution – RDC nº 635, of March 24, 2022; It is

IV – the entry into the country of products brought by travelers by any form of import, including accompanied baggage.

§ 2 Imports for the exclusive purpose of scientific or technological research are excluded from the prohibition contained in the caput of this article, provided that the following requirements are met:

I- carried out by Scientific, Technological and Innovation Institutions duly accredited by the CNPq, as long as the requirements established by the Collegiate Board Resolution – RDC nº 172, of September 8, 2017, are met; It is

…

Art. 4 The use of any electronic device to smoking in a closed collective environment is prohibited, in accordance with Law No. 9,294, of July 15, 1996, and Decree No. 2,018, of October 1, 1996, as well as its updates .

Art.5. ANVISA will periodically carry out systematic reviews of the literature on the topic, whenever there is technical-scientific justification.

….

Art. 6. Failure to comply with this Resolution constitutes a health infraction, subjecting violators to the penalties of Laws No. 9,294, of July 2, 1996 and No. 6,437, of August 20, 1977, and other applicable sanctions, without prejudice to civil, administrative and criminal responsibilities. applicable.

The final adopted regulation is here.